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The objective of this phase I controlled clinical trial is to determine the safety and efficacy of Berry leaves & Mango leaves mixture in symptomatic treatments on disease-related quality of life in adults with clinically diagnosed acute rhinosinusitis. Ten adult subjects, 18 to 70 years old, who meet the recommended criteria for acute rhinosinusitis, will be enrolled from Minia university ENT outpatient Clinic. Subjects will be advised to add Berry leaves & Mango leaves herbal tea mixture and followed for one month with their routine therapy (an oral decongestant, a nasal saline spray, and an antitussive agent except analgesic). Subject outcomes will be assessed by telephone interview at 0, 3, 7, 10, and 28 days. The Quality-of-life outcomes are measured on Day 3, 10 and 28 with SNOT-16, a validated evaluative instrument.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| herbal tea group | Experimental | Herbal tea 3 mgs three times a day plus oral antibiotic |
|
| Routine therapy | Active Comparator | Steroid plus oral antibiotics in their normal doses |
|
| Nasal irrigation Plus antibiotic | Placebo Comparator | Nasal irrigation daily Plus oral antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mango leaves extract | Dietary Supplement | herbal tea 3 times/day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of SNOT 16 score after treatment | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soad A. Mohamad | Minya | Minya Governorate | 05673 | Egypt | ||
| Deraya university |
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| ID | Term |
|---|---|
| D000096825 | Rhinosinusitis |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D012852 | Sinusitis |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| local steroids |
| Drug |
local steroids once daily |
|
| nasal saline | Other | nasal irrigation on need |
|
| amoxicillin clavulanates | Drug | 500 mg 3 times a day |
|
| Minya |
| 05673 |
| Egypt |
| D010254 |
| Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D017670 |
| Sodium Compounds |